Neoadjuvant chemotherapy versus debulking surgery in advanced tubo-ovarian cancers: pooled analysis of individual patient data from the EORTC 55971 and CHORUS trials
| Autor: | Ignace Vergote, Corneel Coens, Matthew Nankivell, Gunnar B Kristensen, Mahesh K B Parmar, Tom Ehlen, Gordon C Jayson, Nick Johnson, Ann Marie Swart, René Verheijen, W Glenn McCluggage, Tim Perren, Pierluigi Benedetti Panici, Gemma Kenter, Antonio Casado, Cesar Mendiola, Gavin Stuart, Nick S Reed, Sean Kehoe, Claes Tropé G., Stephen Dobbs, Sharadah Essapen, P. Hoskins, John Green, E. Gilby, M. Van Baal, Jeremy Twigg, Maria E.L. Van Der Burg, Keith Godfrey, Angel J. Lacave, R. Angioli, Rahul Nath, Kirk Chin, Charles Redman, R. Lotocki, Adeola Olaitan, B. Mosgaard, G. Rustin, Thomas Ind, Mojca Persic, Martin Hogg, J. Van Der Velden, J. Ledermann, Peter Sykes Peter Sykes, Krishnawam Madhavan, P. Kannisto, Vicky Hird, A. Evans, R. Sandvei R., P. Gauthier, D.J. Cruickshank, P.B. Ottevanger, Sheila Pearson, Henry Kitchener, Marcia Hall, P. Bessette, S. Pecorelli, E. Gerdin, Tito Lopes, Andrew Fish, Clare Barlow., K. Van Eygen, A. Floquet, B. Tholander, N. Gul, Robert Gornall, David Luesley, Philip Kirwan, Paul Symonds, Richard Henry, David Poole, Ian McNeish, Mark Hocking, Al Sammaraie, P. Speiser, E. Leblanc, J.A. Green, C.F. De Oliveira, R. Grimshaw, P. Zola, David Parkin, Martin Lamb, Anne Hong, Alan Gillespie, Abdel Hamid, Ahmed Ahmed, M. Plante, B. De Valk, A. Nordin, Andrew Clamp, David Perez, Graham Dark Graham Dark, Michelle Ferguson, Carol MacGregor, Geraldine Skailes, Rachel Jones, G. Cawdell, Simon Leeson, L. Elit, C. Dittrich, W. Gotlieb, John Cullimore, Barbara Crosse, Paul Ridley, Anthony Head, Joaquin Nieto, Saif Awwad, Dirk Brinkmann, Damian Eustace, Andrew Hindley, D. Katsaros, C. Popadiuk, Tome Kristeller, C. Redman, S. Chan, C. Marth, Dennis Yiannakis, Kate Lankaster, Gareth Beynon, Anwar Suhail, Fernando Indrajit, Mary Quigley, Olu Adeyemi, Fiona Lofts, Orla McNally, Amanda Tristam, Martin Lee, R. Counsell, N. Gleeson, A. Papadopoulos, T. Maggino, A. Honkoop, P. Ghatage, J.B. Vermorken, J. De Greve, K. Boman, E Petru, F. Amant |
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| Přispěvatelé: | VU University medical center, CCA - Cancer Treatment and quality of life, Amsterdam Reproduction & Development (AR&D), Obstetrics and gynaecology, Obstetrics and Gynaecology, CCA -Cancer Center Amsterdam, Physiology, ACS - Heart failure & arrhythmias |
| Rok vydání: | 2018 |
| Předmět: |
0301 basic medicine
Oncology Tubo-ovarian Time Factors FIGO Stage IIIA medicine.medical_treatment 0302 clinical medicine Gynecologic Surgical Procedures Risk Factors Multicenter Studies as Topic Stage (cooking) Peritoneal Neoplasms Randomized Controlled Trials as Topic Ovarian Neoplasms Manchester Cancer Research Centre Hazard ratio Obstetrics and Gynecology General Medicine Cytoreduction Surgical Procedures Middle Aged Debulking Neoadjuvant Therapy Progression-Free Survival Tumor Burden Women's cancers Radboud Institute for Health Sciences [Radboudumc 17] EORTC Pooled analysis 030220 oncology & carcinogenesis Female medicine.medical_specialty 03 medical and health sciences All institutes and research themes of the Radboud University Medical Center Internal medicine Carcinoma medicine Fallopian Tube Neoplasms Humans Stage IIIC 1112 Oncology and Carcinogenesis Oncology & Carcinogenesis Aged Neoplasm Staging Chemotherapy business.industry ResearchInstitutes_Networks_Beacons/mcrc Cancer Patient data medicine.disease Surgery 030104 developmental biology Ovarian cancer business MRC CHORUS study investigators |
| Zdroj: | Lancet Oncology, 19, 12, pp. 1680-1687 Obstetrical and Gynecological Survey, 74(3), 156-158. Lippincott Williams and Wilkins MRC CHORUS study investigators 2018, ' Neoadjuvant chemotherapy versus debulking surgery in advanced tubo-ovarian cancers: pooled analysis of individual patient data from the EORTC 55971 and CHORUS trials ', The Lancet Oncology, vol. 19, no. 12, pp. 1680-1687 . https://doi.org/10.1016/S1470-2045(18)30566-7 Vergote, I, Coens, C, Nankivell, M, Kristensen, G B, Parmar, M K B, Ehlen, T, Jayson, G C, Johnson, N, Swart, A M, Verheijen, R, McCluggage, W G, Perren, T, Panici, P B, Kenter, G, Casado, A, Mendiola, C, Stuart, G, Reed, N S & Kehoe, S 2019, ' Neoadjuvant chemotherapy versus debulking surgery in advanced tubo-ovarian cancers: Pooled analysis of individual patient data from the EORTC 55971 and CHORUS trials ', Obstetrical and Gynecological Survey, vol. 74, no. 3, pp. 156-158 . https://doi.org/10.1097/01.ogx.0000554460.78765.59 Jayson, G 2018, ' Neoadjuvant chemotherapy versus debulking surgery in advanced tubo-ovarian cancers: pooled analysis of individual patient data from the EORTC 55971 and CHORUS trials. ', Lancet Oncology, vol. 19, no. 12, pp. 1680-1687 . https://doi.org/10.1016/S1470-2045(18)30566-7 Lancet Oncology, 19, 1680-1687 The Lancet Oncology, 19(12), 1680-1687. Lancet Publishing Group |
| ISSN: | 0029-7828 1680-1687 1470-2045 |
| Popis: | Summary Background Individual patient data from two randomised trials comparing neoadjuvant chemotherapy with upfront debulking surgery in advanced tubo-ovarian cancer were analysed to examine long-term outcomes for patients and to identify any preferable therapeutic approaches for subgroup populations. Methods We did a per-protocol pooled analysis of individual patient data from the European Organisation for Research and Treatment of Cancer (EORTC) 55971 trial ( NCT00003636 ) and the Medical Research Council Chemotherapy Or Upfront Surgery (CHORUS) trial (ISRCTN74802813). In the EORTC trial, eligible women had biopsy-proven International Federation of Gynecology and Obstetrics (FIGO) stage IIIC or IV invasive epithelial tubo-ovarian carcinoma. In the CHORUS trial, inclusion criteria were similar to those of the EORTC trial, and women with apparent FIGO stage IIIA and IIIB disease were also eligible. The main aim of the pooled analysis was to show non-inferiority in overall survival with neoadjuvant chemotherapy compared with upfront debulking surgery, using the reverse Kaplan-Meier method. Tests for heterogeneity were based on Cochran's Q heterogeneity statistic. Findings Data for 1220 women were included in the pooled analysis, 670 from the EORTC trial and 550 from the CHORUS trial. 612 women were randomly allocated to receive upfront debulking surgery and 608 to receive neoadjuvant chemotherapy. Median follow-up was 7·6 years (IQR 6·0–9·6; EORTC, 9·2 years [IQR 7·3–10·4]; CHORUS, 5·9 years [IQR 4·3–7·4]). Median age was 63 years (IQR 56–71) and median size of the largest metastatic tumour at diagnosis was 8 cm (IQR 4·8–13·0). 55 (5%) women had FIGO stage II–IIIB disease, 831 (68%) had stage IIIC disease, and 230 (19%) had stage IV disease, with staging data missing for 104 (9%) women. In the entire population, no difference in median overall survival was noted between patients who underwent neoadjuvant chemotherapy and upfront debulking surgery (27·6 months [IQR 14·1–51·3] and 26·9 months [12·7–50·1], respectively; hazard ratio [HR] 0·97, 95% CI 0·86–1·09; p=0·586). Median overall survival for EORTC and CHORUS patients was significantly different at 30·2 months (IQR 15·7–53·7) and 23·6 months (10·5–46·9), respectively (HR 1·20, 95% CI 1·06–1·36; p=0·004), but was not heterogeneous (Cochran's Q, p=0·17). Women with stage IV disease had significantly better outcomes with neoadjuvant chemotherapy compared with upfront debulking surgery (median overall survival 24·3 months [IQR 14·1–47·6] and 21·2 months [10·0–36·4], respectively; HR 0·76, 95% CI 0·58–1·00; p=0·048; median progression-free survival 10·6 months [7·9–15·0] and 9·7 months [5·2–13·2], respectively; HR 0·77, 95% CI 0·59–1·00; p=0·049). Interpretation Long-term follow-up data substantiate previous results showing that neoadjuvant chemotherapy and upfront debulking surgery result in similar overall survival in advanced tubo-ovarian cancer, with better survival in women with stage IV disease with neoadjuvant chemotherapy. This pooled analysis, with long-term follow-up, shows that neoadjuvant chemotherapy is a valuable treatment option for patients with stage IIIC–IV tubo-ovarian cancer, particularly in patients with a high tumour burden at presentation or poor performance status. Funding National Cancer Institute and Vlaamse Liga tegen kanker (Flemish League against Cancer). |
| Databáze: | OpenAIRE |
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